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Glytone Clarifying Gel

Generic Name: hydroquinone
Dosage Form: gel

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Glytone Clarifying Gel

Skin Bleaching Clarifying Gel

HYDROQUINONE USP, 4%

RX only

FOR EXTERNAL USE ONLY

I. DESCRIPTION

Each 1 gram dose of Clarifying Gel contains 40 mg of Hydroquinone USP in a gel base of Purified Water, Propylene Glycol, Carbomer 940, Sodium Bisulfite, Edetate Disodium, Sorbic Acid, Glycerin.

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II. CLINICAL PHARMACOLOGY

Topical application of hydroquinone produces a reversible depigmentation of the skin by inhibition of the enzymatic oxidation of tyrosine to 3, 4- dihydroxyphenylalanine (dopa) and suppression of other melanocyte metabolic processes. Exposure to sunlight or ultraviolet light will cause repigmentation of the bleached areas.

III. INDICATIONS AND USAGE

Clarifying Gel is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation. It is intended for night-time use only since it contains no sunscreen agents. For daytime usage, Glytone SunVanish should be prescribed.

IV. CONTRAINDICATIONS

Prior history of sensitivity or allergic reaction to this product or any of its ingredients. The safety of topical hydroquinone use during pregnancy or in children (12 years and under) has not been established.

V. WARNINGS

A. CAUTION: Hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed. The physician should be familiar with the contents of this insert before prescribing or dispensing this medication.

B. Test for skin sensitivity before using Clarifying Gel by applying a small amount to an unbroken patch of skin and check in 24 hours. Minor redness is not a contraindication, but where there is itching or vesicle formation or excessive inflammatory response, further treatment is not advised. Close patient supervision is recommended. Avoid contact with eyes. In case of accidental contact, patient should rinse eyes thoroughly with warm water and contact their physician. If no bleaching or lightening effect is noted after 2 months of treatment, Clarifying Gel should be discontinued.

C. There are no sunscreening agents in Clarifying Gel and since minimal sunlight exposure may reverse the bleaching effect of this preparation, it should be used only at night or on areas of the body covered by protective clothing. During the daytime, a broad spectrum sunscreen and protective clothing should be used to prevent the bleached areas from repigmentation. For daytime bleaching of unwanted pigmented areas, the use of Glytone SunVanish should be considered.

D. Keep this and all medication out of the reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.

E. WARNING: Contains sodium bisulfite, a sulfite that may cause allergic-type reactions (e.g. hives, itching, wheezing, anaphylaxis, severe asthma attack) in certain susceptible persons. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

VI. PRECAUTIONS

SEE WARNINGS

A. Pregnancy Category C. Animal reproduction studies have not been conducted with topical hydroquinone. It is also not known whether hydroquinone can cause fetal harm when used topically on a pregnant woman or affect reproductive capacity. It is not known to what degree, if any, topical hydroquinone is absorbed systemically. Topical hydroquinone should not be used in pregnant women.

B. Nursing mothers. It is not known whether topical hydroquinone is absorbed or excreted in human milk. This product is not recommended for use by nursing mothers.

C. Pediatric usage. Safety and effectiveness in children below the age of 12 years have not been established. Do not use on children under 12 years of age.

VII. ADVERSE REACTIONS

No systemic adverse reactions to hydroquinone have been reported. Occasional hypersensitivity (localized contact dermatitis) may occur in which case the medication should be discontinued and the physician notified immediately. Sensitivity to sodium bisulfite is a potential. See WARNINGS.

VIII. OVERDOSAGE

There have been no systemic reactions from the use of topical hydroquinone in Clarifying Gel in recommended quantities. However, treatment should be limited to relatively small areas of the body at one time since some patients experience a transient skin reddening and a mild burning sensation which does not preclude treatment, but indicates caution is warranted.

IX. DRUG DOSAGE AND ADMINISTRATION

Clarifying Gel should be applied nightly to the affected area and rubbed in well or as directed by your physician to achieve maximum therapeutic potential. During the day, an effective broad spectrum sunscreen should be used and unnecessary sun exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring.

X. HOW SUPPLIED

Clarifying Gel is available as follows:

Size   NDC Number 
Net Wt. 56 g / 2 Oz. bottle    64760-202-01

Clarifying Gel should be stored at controlled room temperature 15° - 30° C ( 59° - 86° F). Do not expose to heat above 86° F or direct sunlight.

  

Distributed by:

Genesis Pharmaceutical, Inc.

Parsippany, NJ 07054

Made in U.S.A.

1-800-GLYTONE (459-8663)

www.glytone-usa.com

Rev. 082813

  

Principal Display Panel - Clarifying Gel Carton 56 g

NDC 64760-202-01

GLYTONE

CLARIFYING

Rx ONLY

skin bleaching

clarifying gel

HYDROQUINONE USP, 4%

NET WT. 2 Oz. (56 g)

GLYTONE CLARIFYING 
hydroquinone gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64760-202
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
PROPYLENE GLYCOL  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)  
SODIUM BISULFITE  
EDETATE DISODIUM  
SORBIC ACID  
GLYCERIN  
Packaging
# Item Code Package Description
1 NDC:64760-202-01 1 BOTTLE, PLASTIC in 1 CARTON
1 56 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 11/09/2010
Labeler - Genesis Pharmaceutical, Inc. (117196928)
Revised: 08/2014
 
Genesis Pharmaceutical, Inc.



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